Tempus Introduces xM, An Assay to Monitor Immunotherapy Response for Patients with Advanced Cancers

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced xM for treatment response monitoring (TRM), a liquid biopsy assay intended to detect molecular response to immune-checkpoint inhibitor (ICI) therapy in advanced solid tumors. xM for TRM is the newest addition to Tempus’ growing portfolio of sensitive assays for monitoring molecular response and minimal residual disease (MRD). It is currently available for research use only, with clinical availability expected later this year.

In 2023, an estimated 56.55% of patients with advanced or metastatic cancers were eligible for ICIs, with a corresponding estimated response rate of 20.13%.¹ xM for TRM is designed to quantify changes in circulating tumor DNA (ctDNA) longitudinally from a blood sample, enabling early molecular response assessment in patients with advanced cancers receiving immunocheckpoint inhibitors (ICI) alone or combination therapies. xM for TRM leverages a unique multi-parametric algorithm, integrating copy number variations (CNVs), along with somatic and germline variant allele frequencies (VAFs), for a comprehensive and robust estimation of circulating tumor fraction.

Tempus is presenting new data on xM for TRM at the 2025 American Society of Clinical Oncology (ASCO®) Annual Meeting, highlighting the assay’s potential to help clinicians monitor response and refine treatment strategies for patients with advanced cancers.

• Title: A molecular biomarker for longitudinal monitoring of therapeutic efficacy in a real-world cohort of advanced solid tumors treated with immune checkpoint inhibitors
• Date/Time: June 2, 2025; 1:30 PM-4:30 PM CDT
• Location: Poster Section Developmental Therapeutics—Immunotherapy (Poster #205)
• Overview: Tempus xM for TRM, a liquid biopsy test, monitors treatment response by tracking ctDNA dynamics over time. Longitudinal non-molecular responders are associated with worse survival compared to molecular responders, highlighting the value of xM molecular response monitoring as a tool to guide ICI treatment decisions.

“Our comprehensive monitoring portfolio is designed to support patients throughout the cancer treatment journey,” said Halla Nimeiri, MD, Chief Development Officer at Tempus. “We're excited to introduce a new assay of molecular response for both physicians and biopharma researchers that can timely track changes of quantitative tumor fraction while patients receive ICI therapies. This may impact treatment decisions, especially for patients with advanced disease, where timing is absolutely critical. With xM for TRM, clinicians can detect molecular response to ICI prior to six weeks into treatment, enabling them to stay ahead of disease progression and optimize therapeutic strategies.”

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential impact of xM TRM and other tests, the indicated use of the xM TRM and other tests for potential clinical use, and the timing of the availability of such testing, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2025, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

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